2 0+ YEARS EXPERIENCE IN MEDICAL DEVICE BUSINESS FOR:
• New Product Development
• Design Control
• Regulations (ISO 13485, MDR, ISO 14971, FDA 21 CFR 820.30, ect ...)
• Technical Project Management

WE OFFER SERVICES FOR:
• Product Development: Project Management, technical documentation and remediation actions
• Project assessment for both start-ups and well established companies
• Temporary management of R&D and QA&RA
• Technical tutoring and mentoring for new managers in R&D and QA&RA

TRAININGS IN AREAS SUCH AS:
• New Product Development
• Medical devices
• R&D
• QA&RA (Quality Assurance and Regulatory Affairs)

We work with partners in the areas of mechanical engineering, IP, strategic marketing, project financing initiatives and process validation.

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